Sepsis in the ICU-II

NCT ID: NCT04695119

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-17
• Study Completion Date: 2025-12-31

Brief Summary

Sepsis-induced cardiac dysfunction (SIMD) is a well-known phenomenon yet its diagnosis remains elusive with no accepted definition, or defining pathophysiological mechanism associated with this disease. Systolic dysfunction occurs in 20-70% of patients, and may be severe, yet does not appear to have any prognostic value for mortality. Diastolic function has also been variably described and seems to be related to short-term mortality. However, the contribution of left ventricular systolic and diastolic dysfunction to mortality in sepsis are still far from clear, with uncertain contribution from previous cardiovascular disease, vasopressor and inotropic drugs and mechanical ventilation. Another poorly investigated area is right ventricular dysfunction. Cor pulmonale occurs in up to 25% of patients with septic shock, and is invariably related to pulmonary haemodynamics and mechanical ventilation, yet very little is known about how this affects prognosis. Finally, although the outcome of disease is a function of multiple parameters, septic cardiomyopathy is most frequently characterized based on individual echocardiographic parameters, without considering their interactions or placing them in the context of biomarkers and clinically available haemodynamic data. Available relevant studies are often monocentric, and many fail to consider the various confounders that influence the clinical outcome in sepsis. Therefore, the diagnostic and prognostic value of combinations of clinical, biochemical and haemodynamic variables remains to be established.

Accordingly, the purpose of this study is to identify biomarkers and echocardiographic and haemodynamic signatures characteristic of specific outcomes in SIMD to support the diagnosis and prognosis in SIMD. Specific aims are:

1. To determine the association between left ventricular systolic and diastolic dysfunction, and adverse outcome in SIMD;

2. To determine the association between right ventricular systolic and diastolic dysfunction, and adverse outcome in SIMD;

3. To determine the association between novel biomarkers and adverse outcome in SIMD;

4. To determine the combined value of biomarker, echocardiographic, and haemodynamic variables for predicting adverse outcomes in SIMD;

5. To explore if there are different phenotypes of SIMD using unsupervised machine learning algorithms, and whether they are associated with adverse outcomes.

50 patients will be enrolled in a feasibility study to evaluate the logistical setup for acute echocardiography and biobanking facilities. A further 300 patients will be enrolled with inclusion from peripheral centers once feasibility is confirmed.

Detailed Description

UPDATE 26 Feb 2022:

A pilot project was completedafter recruitment of 50 patients confirming the feasibility of data collection, study logistics, biomarker assay set-up and frequency of outcomes. Cancellation of non-COVID related research in 2020&2021 has caused significant delays. Recruitment of patients will continue during 2022&2023. At the time of writing 70 patients have been recruited across 4 centres.

Conditions

Septic Shock; Sepsis; Cardiomyopathies; Organ Failure, Multiple

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adult patients with septic shock

All adult (>=18 yo) patients admitted to participating ICUs with septic shock defined according to the Sepsis III criteria.

Purely observation study with no intervention. Patients are exposed to septic shock and treatment according to standard departmental protocols at each centre.

Exposure is septic shock (defined according to Sepsis-III) and standard treatment according to departmental protocols.

Intervention Type: OTHER

Collection of data, biomarker and echocardiography analysis will be centralized and blinded. Assessment of endpoints will be blinded.

Interventions

Exposure is septic shock (defined according to Sepsis-III) and standard treatment according to departmental protocols.

Collection of data, biomarker and echocardiography analysis will be centralized and blinded. Assessment of endpoints will be blinded.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult patients admitted to ICU and fulfilling the Sepsis-III criteria for septic shock

Exclusion Criteria

• No informed consent
• Acute coronary syndromes

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: collaborator

Ryhov Hospital, Jönköping

UNKNOWN

Sponsor Role: collaborator

Bicetre Hospital

OTHER

Sponsor Role: collaborator

Hôpital Européen George Pompidou, APHP, Paris, France

UNKNOWN

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Michelle Chew

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Chew, MBBS, PhD

Role: STUDY_CHAIR

Linkoeping University Hospital

Bernard Cholley, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU George Pompidou

Belaid Bouhemad, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Dijon

Fredrik Hammarsköjld, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ryhov Hospital, Jönköping

Xavier Monnet, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Bicetre

Locations

CHU Dijon-Bourgogne

Dijon, Dijon, France

Site Status: RECRUITING

CHU Georges Pompidou

Paris, Paris, France

Site Status: RECRUITING

Ryhov Sjukhus Jönköping

Jönköping, Jönköping County, Sweden

Site Status: NOT_YET_RECRUITING

Dept of Anaesthesia and Intensive Care

Linköping, , Sweden

Site Status: RECRUITING

Countries

France; Sweden

Central Contacts

Michelle S Chew, MBBS, PHD

Role: CONTACT

michelle.chew@liu.se

+46101030000

Henrik Andersson, MSc, PhD

Role: CONTACT

henrik.a.andersson@regionostergotland.se

+46101030000

Facility Contacts

Belaid Bouhemad

Role: primary

Belaid Bouhemad, MD, PhD

Role: backup

Bernard Cholley, MD, PhD

Role: primary

Fredrik Hammarskjöld, MD, PhD

Role: primary

Fredrik Hammarskjöld

Role: backup

Henrik Andersson, PhD

Role: primary

Helen Didriksson, RN

Role: backup

References

Blixt PJ, Nguyen M, Cholley B, Hammarskjold F, Toiron A, Bouhemad B, Lee S, De Geer L, Andersson H, Aneq MA, Engvall J, Chew MS. Association between left ventricular systolic function parameters and myocardial injury, organ failure and mortality in patients with septic shock. Ann Intensive Care. 2024 Jan 18;14(1):12. doi: 10.1186/s13613-023-01235-5.

Reference Type: DERIVED

PMID: 38236316 (View on PubMed)

Other Identifiers

SICU-II

Identifier Type: -

Identifier Source: org_study_id